Validation Considerations when selecting an ERP system

When selecting a new ERP system in the pharmaceutical industry, certain considerations from Computer System Validation (CSV) perspective need to be taken into account:

  • Do I need to validate my ERP system?
  • What predicate rules apply for my type of industry (API, Medicinal Products, Clinical trials, or Medical devices)?
  • In what part of the world are my manufacturing sites and my end markets and how do the regulations impact this?
  • Are you going to use Digital Signatures for approving documents?
  • What are the requirements for Business Continuity?
  • How does this impact your vendor and system choice?

Depending on your situation, we can provide you with the appropriate advice and next steps. The best advice Q7 Consulting can give you now is that you have full clarity on the aforementioned topics prior to sign a contract with your vendor for a new or upgraded ERP system.